US 20090209804 A1
Apparatuses and methods for percutaneously implanting objects, such as radioactive seeds or markers, in patients. In one embodiment, a device for percutaneously implanting an object in a patient includes a handle, a cannula projecting outwardly from the handle, and an actuator movably disposed relative to the handle. In one aspect of this embodiment, the cannula can be configured to releasably hold the object and percutaneously penetrate the patient. In another aspect of this embodiment, the actuator can be operably connected to the cannula and operable to move the cannula relative to the handle and release the object within the patient. In a further aspect of this embodiment, the cannula can include a tip portion having a restriction configured to releasably hold the object for implantation in the patient.
1. A device for percutaneously implanting marker in a patient, the device comprising:
an elongated stylet having a proximal section and a distal section;
a first handle attached to the proximal section of the stylet;
a cannula having a proximal portion configured to receive the stylet and a distal portion configured to retain the marker;
a second handle attached to the proximal portion of the cannula; and
a retainer engaged with the first and the second handles, the retainer being configured to restrict relative movement between the first and second handles in a longitudinal direction.
2. The device of
3. The device of
4. The device of
the first handle has a first collar;
the second handle has a second collar; and
the retainer further comprises a first C-clamp engaged with the first handle next to the first collar, and a second C-clamp engaged with the second handle next to the second collar.
5. The device of
6. The device of
7. The device of
8. The device of
9. The device of
10. The device of
11. A device for implanting a marker into a patient, the marker having an alternating magnetic transponder that wirelessly transmits a location signal in response to a wirelessly transmitted excitation energy, the device comprising:
a cannula having a wall, a proximal portion, and a distal portion;
a marker holder at the proximal portion and/or the distal, portion of the cannula, wherein the marker holder is configured so that the location signal can propagate through the marker holder to a sensor.
12. The device of
13. The device of
14. The device of
15. The device of
a dielectric housing having a chamber configured to receive the marker; and
a retaining element in the cavity for releasably retaining the marker in the cavity.
16. The device of
a dielectric housing having a cavity configured to contain a marker and an opening in which the distal portion of the cannula is positioned; and
a first retaining element in the cavity.
17. The device of
18. The device of
19. The device of
20. The device of
21. The device of
22. The device of
23. The device of
a dielectric housing having a cavity configured to contain a marker and an opening configured to receive a stylet; and
a retaining element in the cavity for holding the marker.
24. The device of
25. The device of
26. A device for implanting marker in a patient, the device comprising:
a cannula having an interior channel, a proximal portion, and a distal portion configured to retain the marker,
a handle attached to the proximal portion of the cannula, the handle having a hub in communication with the interior channel; and
a marker container having a connection portion and a chamber coupled to the connection portion, the connection portion being releasably coupleable to the hub with the chamber in communication with the interior channel to deliver the marker from the chamber into the interior channel.
27. The device of
28. The device of
29. The device of
30. A device for percutaneously Implanting an object in a patient, the device comprising:
a handle having an opening;
a stylet having a proximal section fixed to the handle, a medial section through the opening in the handle, and a distal section outside of the handle;
a cannula over at least a portion of the stylet, the cannula having a proximal portion slidably received through the opening of the handle and a distal portion configured to releasably hold the object; and
an actuator connected to the proximal portion of the cannula and received in the handle.
31. The device of
32. The device of
33. The device of
34. The device of
35. The device of
36. The device of
37. The device of
38. The device of
39. A device for percutaneously implanting an object in a patient, the device comprising:
a handle; and
a cannula having a wall and distal portion configured to releasably hold the object, wherein the cannula has a hole through the wall through which an electromagnetic signal can propagate.
40. The device of
41. The device of
42. A device for holding a marker and loading the marker into a cannula, the device comprising:
a dielectric housing having a cavity and an opening at one end of the cavity; and
a resilient retaining element in the cavity having an inner diameter less than a diameter of the marker.
43. The device of
44. The device of
45. The device of
46. The device of
a second retaining element at a proximal portion of the cavity;
a stop element distally of the first retaining element; and
an annulus around the stop element.
47. An assembly, comprising:
a marker having a casing and an alternating magnetic transponder in the casing, the transponder having a ferrite core and a coil wrapped around the core, and wherein the transponder wirelessly transmits a resonating location signal in response to a wirelessly transmitted excitation energy; and
a marker holder having a dielectric housing, a cavity in the housing in which the marker is received, an opening at a proximal end of the housing, and a retaining element in the cavity having a resilient contact surface contacting the casing of the marker.
48. The assembly of
49. The assembly of
50. The assembly of
a second retaining element at a proximal portion of the cavity;
a stop element distally of the first retaining element; and
an annulus around the stop element.
51. A cannula for use in percutaneously implanting an object in, a patient, the cannula comprising a tube having a wall, a proximal inlet configured to receive the object, an intermediate portion extending distally from the proximal inlet, a distal portion extending distally from the intermediate portion, a tip with a cutting edge configured to penetrate the skin of the patient at the distal portion, a restriction at the cutting edge configured to releasably hold the object within the cannula, and a hole through the wall proximate to the distal tip to allow an electromagnetic signal to propagate from the cannula.
52. A method for percutaneously implanting an object in a patient, the method comprising:
restricting relative movement between a cannula and a stylet in a longitudinal direction with respect to a longitudinal axis of the cannula by engaging a retainer with the cannula and the stylet;
driving the cannula and the stylet into the patient while restricting relative longitudinal movement therebetween;
releasing the retainer to allow relative movement between the cannula and the stylet; and
drawing the cannula proximally over the stylet.
53. A method for handling a marker configured to be implanted into a patient, the marking having a transponder configured to wirelessly transmit a location signal in response to a wirelessly transmitted excitation energy, the method comprising:
loading the marker into a marker holder through which the location signal can propagate;
energizing the marker by wirelessly transmitting the excitation energy to the marker; and
sensing the location signal wirelessly transmitted from the marker through the marker holder.
54. The method of
55. The method of
56. The method of
57. The method of
58. The method of
59. The method of
60. The method of
61. The method of
62. A method for testing a marker and percutaneously implanting the marker in a patient, the method comprising:
energizing the marker while in a non-conducting container coupled to a proximal end and/or a distal end of a cannula;
loading the marker into the cannula;
driving cannula and the marker into the patient; and
moving the cannula in a proximal direction relative to a stylet in the cannula to release the marker within the patient.
This application is a continuation-in-part of application Ser. No. 10/334,699, filed on Dec. 30, 2002. This application claims the benefit of and priority to U.S. provisional patent application no. 60/590,521 filed on Jul. 23, 2004, which is hereby incorporated in its entirety herein by reference.
The following disclosure relates generally to medical devices for percutaneously implanting markers or other small objects in patients.
A number of existing medical treatments involve percutaneously inserting or implanting objects in a patient. One such treatment is brachytherapy for prostate cancer. In brachytherapy, radioactive sources or “seeds” are implanted relative to a tumor to provide a high dose of radiation to the tumor but not the surrounding healthy tissue. Other oncological treatments involve percutaneously implanting radio-opaque markers or signal-generating markers adjacent to the tumor. The markers identify the location of the tumor so that a high dose of radiation from a linear accelerator or other external source can be focused directly at the tumor.
To implant the seeds 110 at a target location in a patient (not shown) in the desired pattern as loaded in the cannula 108, an operator (also not shown) pushes the cannula 108 in a first direction 120 to insert the tip 105 into the patient. The operator then pushes the second handle 103 further in the first direction 120 to position the tip 105 at the desired depth within the patient where the seeds 110 are to be released. Throughout this motion, the operator moves the needle 102 and the stylet 104 together as a unit. At the desired depth, the operator grasps the first handle 101 with one hand and the second handle 103 with the other hand and, while holding the first handle 101 stationary, slides the second handle 103 back in a second direction 122 toward the first handle 101. As shown in
One shortcoming of the prior art introducer 100 is that the two-handed movement required to properly release the seeds 110 at the target location and in the desired pattern may be somewhat awkward and nonintuitive. As a result, the operator is prone to err and may inadvertently misplace the seeds 110. For example, to properly release the seeds 110, the operator must hold the first handle 101 stationary while sliding the second handle 103 back in the second direction 122 toward the first handle 101. If, instead, the operator accidentally pushes the first handle 101 toward the second handle 103, then the stylet 104 may push the seeds 110 out of the cannula 108 in the first direction 120. This movement could cause the seeds 110 and the spacers 111 to collide in a “train wreck” just beyond the tip 105 of the cannula 108. Either way, the seeds will not be positioned accurately relative to the target location or in the desired pattern. A further shortcoming of the prior art introducer 100 is that the bone wax used for the plug 112 in brachytherapy applications may melt prematurely allowing the seeds 110 to migrate out of the cannula 108 before reaching the desired target location. As such, conventional introducers for brachytherapy applications are custom loaded at the treatment facility and are not suitable for being transported in warm environments.
Markers that transmit a signal pose additional challenges for introducers. In the case of markers with magnetic transponders or other radio frequency transmitters, it is desirable to check the functionality and other attributes of the markers after loading the markers in the introducers but before implantation. Assuring functionality of a marker after packaging but before implantation reduces complications caused by implanting a nonfunctioning or a malfunctioning marker. Conventional introducers, which are made of metals and metal alloys, are not well suited for testing markers after the markers have been loaded in the cannulas because the electromagnetic waves emitted by the marker are absorbed by the metal cannulas. As such, even though the cannulas do not completely enclose the markers, they nevertheless can reduce the signal strength outside of the cannulas. Thus, conventional introducers may prevent testing a marker while it is in the introducer.
The invention is directed to apparatuses and methods for implanting markers, radioactive seeds, radio frequency transponders, or other small objects in patients. In one aspect, a device for percutaneously implanting an object in a patient includes a handle, a cannula projecting outwardly relative to the handle, and an actuator operably connected to the cannula and movably disposed relative to the handle. The cannula can have a proximal portion positioned proximate to the handle and a distal portion configured to releasably hold the object and percutaneously penetrate the patient by movement of the handle. The actuator can be operable to slide the cannula relative to the handle and release the object within the patient.
In another aspect, the device can further include a stylet extending at least partially within the cannula and being fixedly positioned with respect to the handle. Operating the actuator to slide the cannula relative to the handle causes the cannula to slide relative to the stationary stylet and release the object within the patient.
In a further aspect, the cannula can include a tip portion having a restriction configured to releasably hold the object for implantation in the patient, and the actuator can be selectively movable from a first position to a second position. When the actuator is in the first position, the tip portion of the cannula can at least generally retain the object. When the actuator is in the second position, the cannula can be drawn back from the object to overcome the restriction and release the object within the patient.
In yet another aspect, a method for percutaneously implanting an object in a patient includes moving a handle to percutaneously insert a cannula projecting from the handle within the patient, and moving the cannula relative to the handle to release the object within the patient. Moving the cannula relative to the handle can include sliding the cannula with respect to a stationary stylet extending coaxially through at least a portion of the cannula. Moving the handle to percutaneously insert the cannula can include driving the handle forward with a hand of an operator. Further, moving the cannula relative to the handle to release the object within the patient can include manipulating an actuator with a digit of the hand of the operator to move the cannula aft relative to the handle while the handle remains stationary in the hand of the operator.
Still another aspect of the invention is directed to an introducer assembly that enables markers with alternating magnetic transponders to be tested while they are assembled with or otherwise loaded in the introducer. In one embodiment, the introducer includes a cannula, a stylet configured to fit in the cannula, and a holder configured to releasably retain a marker. The holder is further configured to allow a sufficient signal level from the marker to propagate from the introducer for testing the marker after it has been assembled with the introducer but before implanting the marker. The holder can be a dielectric housing at a proximal end and/or distal end of the cannula. For example, the holder can include a retaining element that engages a peripheral surface of the marker to retain the marker within the holder. In an alternative embodiment, the holder is a distal portion of the cannula having a hole through the cannula wall. The hole through the cannula wall is large enough to allow a sufficient portion of the electromagnetic signal transmitted from the marker to pass through the cannula wall and be measured by a sensor.
In operation, the marker is initially loaded into the holder for testing. The marker is tested by generating an alternating magnetic excitation field at the resonant frequency of the marker, terminating the excitation field, and sensing a wirelessly transmitted alternating magnetic location signal from the marker. Because the holder is a dielectric housing or a portion of the cannula having holes through the cannula wall, a sufficient amount of energy from the location signal propagates to a sensor. As a result, the markers can be tested after they have been loaded into the introducers to insure that the markers operate before shipping the loaded introducers. Additionally, the markers can also be tested just before they are implanted into the patient to further insure that only operable markers are implanted.
The following disclosure describes medical devices and methods for percutaneously implanting objects, such as radioactive seeds or markers, in patients. Certain specific details are set forth in the following description and in
A signal-generating marker 202, a radio-active seed or other implantable object is slidably positioned in the cannula 240 between the distal end 206 of the stylet 250 and the tip portion 242 of the cannula 240. The tip portion 242 can be configured to percutaneously penetrate the patient for implantation of the marker 202, and can include a restriction 243 configured to releasably retain the marker 202 in the cannula 240 prior to release of the marker 202 in the patient. In other embodiments, the cannula 240 can hold other objects for implantation in the patient in addition to the marker 202. For example, in another embodiment, the cannula 240 can hold additional markers optionally spaced apart by one or more spacers to provide a desired marker pattern. Similarly, in a further embodiment, the cannula 240 can hold a plurality of radioactive seeds optionally spaced apart by one or more spacers to provide a desired seed pattern.
To percutaneously implant the marker 202 in a patient (not shown), an operator 212 grasps the handle 210 in one hand and aligns the cannula 240 with a desired point of entry on the patient. The operator 212 then moves the handle 210 in a forward direction 204 to position the tip portion 242 of the cannula 240 at the target location within the patient (for example, proximate to a tumor). During this movement, the cannula 240 is held stationary relative to the stylet 250. Referring next to
One feature of embodiments of the introducer 200 shown in
In another aspect of this embodiment, the actuator 230 is at least generally hollow and includes a body 330, a bore 332 through the body 330, a position selector 334, and an opening 335 at one end of the body 330 opposite the bore 332. A proximal end of the cannula 240 is positioned in the bore 332 and fixedly attached to the body 330. The cannula 240 can extend from the opening 335 and project outwardly from the bore 332. The position selector 334 of the illustrated embodiment includes an indexing feature or protruding tab 338 and a button pad 337 for mounting the button 220. First and second slits 331 a and 331 b are positioned on opposite sides of the position selector 334 and allow the protruding tab 338 to deflect resiliently inward in response to depression of the button 220.
In a further aspect of this embodiment, the handle 210 is at least generally hollow and includes an interior portion 314 and a cannula opening 319. The interior portion 314 can be configured to slidably receive the actuator 230, and the cannula opening 319 can be configured to allow the cannula 240 to slide freely back and forth with respect to the handle 210 as the actuator 230 moves back and forth within interior portion 314 of the handle 210.
In yet another aspect of this embodiment, the handle 210 further includes a button opening 316 and locking features 318. In the illustrated embodiment, the locking features 318 include a first tab opening 318 a and a second tab opening 318 b. The locking features 318 can be configured to selectively receive the protruding tab 338 of the position selector 334 as the operator (not shown) moves the position selector 334 fore and aft in the handle 210 with the button 220. As will be explained in greater detail below, in other embodiments, the handle 210 can include more locking features depending on the number of markers 202 or other objects the introducer 200 is configured to implant.
The introducer 200 can be assembled by inserting the cannula 240 through the handle opening 312 and the cannula opening 319 until the button pad 337 is aligned with the button opening 316 and the protruding tab 338 engages the first locking feature 318 a. The button 220 is then fixedly attached to the button pad 337. The marker 202 can then be inserted into the cannula 240 through a cannula inlet 343 at the proximal end of the cannula 240. In other embodiments, the marker 202 can be inserted into the distal end of the cannula. The cannula inlet 343 can be flared or otherwise configured for smooth loading of the marker 202 or other objects, such as seeds and/or spacers. The distal end 206 of the stylet 250 is then inserted into the cannula inlet 343 and moved through the cannula 240 driving the marker 202 through the cannula 240 until the engagement portion 362 of the cap 360 mates with the handle opening 312. At this point the marker 202 is releasably held in the cannula 240 between the distal end 206 of the stylet 250 and the restriction 243 of the tip portion 242.
Referring now to
One feature of embodiments of the invention shown in
Yet another feature of embodiments of the invention shown in
Those of ordinary skill in the relevant art will recognize that the structures described above for controlling the position of the cannula 240 relative to the stylet 250 (such as the position selector 334, the button 220, the protruding tab 338, and the locking features 318) represent but one embodiment of the present invention. Accordingly, in other embodiments, the features described above can have other details without departing from the spirit or scope of the invention. For example, in another embodiment, the protruding tab 338 and the locking features 318 can be omitted and the position of the actuator 230 can be manually controlled by the operator 212 or can be controlled by a friction surface, such as a serrated surface, existing between the actuator 230 and the handle 210.
In another aspect of this embodiment, a plurality of markers 602 are slidably positioned in the cannula 640. Accordingly, an operator (not shown) can sequentially release the markers 602 in a patient (also not shown) by sequentially depressing a button 620 and moving the button 620 aft relative to the handle 610. With each aft movement, the protruding tab 638 is selectively received by one of the locking features 618. In this manner, the operator can monitor and control the timing of each marker release. The operator, for example, can implant a first marker 602 at a first target location, reposition the introducer 600, and implant a second marker 602 at a second location without having to reload the introducer 600.
One aspect of the introducer 1100 is that the teeth 1120 along the actuator 230 can be arranged such that a predetermined number of button depressions will drive the actuator 230 and cannula 240 backwards to release a marker from the cannula 240. As such, a plurality of markers can be loaded into the cannula 240 and each marker can be selectively ejected from the introducer by incrementally moving the actuator 230 backward by a set distance to controllably eject only a single marker at a time.
The embodiment of the retainer 1210 illustrated in
The embodiment of the introducer 1300 operates by loading a marker 1304 into the cannula 1302 and holding the marker 1304 at the marker holder 1303. The marker 1304 can be held at the marker holder 1303 by a stylet (not shown) in the cannula 1302. The stylet can be held using a retainer as described above with reference to
The introducer 1400 further includes a marker holder 1410 at the distal portion of the cannula 1404. The marker holder 1410 includes a housing 1412 having a chamber 1414 and a sleeve 1416 projecting proximally from the housing 1412. The housing 1412 has a dielectric body composed of acrylics, polymers, or other suitable dielectric materials. The sleeve 1416 receives the cannula 1404 to guide the distal portion of the cannula 1404 into the chamber 1414. In this embodiment, the marker holder 1410 further includes a first retaining element 1420 a in one portion of the chamber 1414, a second retaining element 1420 b in a different portion of the chamber 1414, and a stop element 1422 projecting through an annulus 1424 at a distal portion of the marker holder 1410.
One advantage of the marker holder 1410 is that the dielectric housing does not significantly attenuate the strength of the marker signal S. Additionally, the marker holder 1410 protects the marker M and inhibits the marker M from inadvertently being ejected from the cannula 1404 until the patient is ready to have the marker M implanted. Moreover, the stylet 1402 can be pre-inserted into the cannula 1404 such that the entire introducer 1400 shown in
The second handle 1703 of the illustrated embodiment includes a hub 1708 at a proximal end 1709. The hub 1708 has an opening 1718 through which the stylet 1702 passes as the stylet Is moved axially into the cannula 1700. The introducer 1600 of the illustrated embodiment also includes a stylet spacer 1710 removably connectable to the stylet 1702 adjacent to the first handle 1701. The stylet spacer 1710 restricts the stylet 1702 from moving too far into the cannula 1700 to prevent a marker (not shown) from being inadvertently discharged from the distal end of the cannula 1700.
The stylet spacer 1710 of the illustrated embodiment includes a generally cylindrical body 1712 with an elongated channel 1714 that removably receives a portion of the stylet 1702 adjacent to the first handle 1701. The body 1712 of one embodiment is made of a partially compressible material, such as a rubber, so the stylet spacer 1710 can allow the stylet 1702 to axially move a small amount relative to the cannula 1700 without damaging the components or discharging the marker. The channel 1714 is sized such that the body 1712 clips onto and frictionally engages the stylet 1701 to hold the stylet spacer 1710 in place on the stylet.
The stylet spacer 1710 is also configured so that a distal end 1711 of the body 1712 extends partially into the hub 1708 through the opening 1718 when the stylet 1702 is positioned in the cannula, as shown in
In the illustrated embodiment, the stylet spacer 1710 also includes a grip portion 1716 attached to the body 1712. The grip portion 1716 provides an area that a user can grip when removing the stylet spacer 1710 from the stylet 1702. In one embodiment, the grip portion 1716 is configured with an area that could include indicia, for example, to identify individual introducers and the markers contained within the introducers. In another embodiment, the stylet spacer 1710 can have a specific color, shape, symbol, or other indicia that indicates the frequency or other aspects of a marker contained in or associated with the introducer 1600, as discussed above.
The interior chamber 1802 of the container body 1800 is sized to receive the marker 1804 through the opening 1816. The interior chamber 1802 of the illustrated embodiment has an inner diameter slightly greater than the exterior diameter of the marker 1804. Accordingly, the marker 1804 can slide axially within the interior chamber 1802, but is substantially restricted by the chamber walls from moving laterally within interior chamber. The container body 1800 in one embodiment is made of a dielectric material, such as parylene or another suitable dielectric material, that will allow the marker 1804 to be tested, as discussed above, when it is in the marker container 1650. The container body 1800 is also configured so it will not scratch the glass casing of the marker 1804.
The enlarged distal portion 1810 of the container body 1800 has internal threads 1820 within the annulus 1812. The annulus 1812 and internal threads 1820 removably receive a cap 1822 that screws into the annulus. In one embodiment, the cap 1822 is made of a dielectric material, such as parylene, that will not interfere with testing of the marker 1804 while it is in the marker container 1602.
The cap 1822 of the illustrated embodiment has a shaft 1824 with an enlarged knob 1826 on one end and external threads 1828 on the other end. The external threads 1828 are adapted to threadably mate with the internal threads 1820 in the annulus 1812. The shaft 1824 includes an aperture 1830 that receives the locking element 1814 when the cap is screwed onto the body portion. Accordingly, the shaft 1824 of the cap 1822 extends over the locking element 1814, covers the interior chamber 1802, and retains the marker 1804 in the container body 1800 until the cap 1822 is unscrewed and removed from the container body. In the illustrated embodiment, the internal and external threads 1820 and 1828 are conventional 6° locking luer threads that allow the cap to be quickly and easily removed from the chamber body 1800 to provide access to the locking element 1814.
In the illustrated embodiment, the container body 1800 is configured to allow a user to grasp the container body as the cap 1822 is unscrewed from the container body. In one embodiment, the container body 1800 has a gripping region 1808 formed by a pair of flanges 1806 project radially from a proximal portion 1809 of the container body 1800. Other embodiments can have container bodies 1800 with alternate configurations that allow a user to comfortably remove the cap 1822 from the container body.
In one embodiment, the knob 1826 of the cap 1822 has indicia 1832 on an exterior surface 1834 that can be used to identify the marker contained within the marker container 1800. In one embodiment, the indicia may be letters, numbers, symbols, colors or other indicia. In other embodiments, the cap 1822 can have different shapes or colors that provide an indication to a user which marker 1804 is contained in the marker container 1602.
The marker container assembly 1602 protects and isolates the marker 1804 until the marker 1804 is to be loaded into the introducer 1600 (
After the container body 1800 is attached to the hub 1708, the introducer 1600 and the container body 1800 can be oriented as a unit so that gravity drops the marker 1804 into the cannula 1700. The container body 1800 can then be removed from the hub 1708, and the stylet 1702 (
Although specific embodiments of, and examples for, the present invention are described herein for illustrative purposes, various modifications can be made without departing from the spirit and scope of the invention as will be readily apparent to those of ordinary skill in the relevant art. For example, although introducers are described above for implanting wireless active markers, the teachings of the present invention can also be applied to introducers for implanting markers that are hard-wired to a power source external to the patient. In these embodiments, for example, a suitable hole or other outlet can be provided in the introducer handle as required to accommodate passage of the wire. In addition, although the present disclosure describes manual introducers, in other embodiments, powered introducers that are at least partially automated can also be configured in accordance with embodiments of the present invention.
From the foregoing, it will be appreciated that specific embodiments of the invention have been described herein for purposes of illustration, but that various modifications may be made without deviating from the spirit and scope of the invention. Accordingly, the invention is not limited except as by the appended claims.
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